摘要
目的:为我国儿童基本药物目录的制定提供参考。方法:采用描述性分析方法,比较2023年版《世界卫生组织儿童基本药物目录》(EMLc)和2018年版《国家基本药物目录》(NEML)中收录的抗肿瘤药物的品种、剂型、规格、适应证等方面的差异,并对EMLc收录特有的抗肿瘤药物在我国的上市情况进行统计分析。结果:品种方面,两目录共同收录的抗肿瘤药物有26种,EMLc收录的博来霉素等18种抗肿瘤药物未被NEML收录;剂型方面,EMLc收录的抗肿瘤药物剂型更为丰富;规格方面,EMLc和NEML均收录有适合儿童使用的规格;适应证方面,NEML所有药物均未标注适应证,仅三氧化二砷的适应证在EMLc、国产制剂说明书和美国食品药品监督管理局说明书中完全相同;EMLc收录的特有抗肿瘤药物除了非格司亭和拉布立酶,其余均在我国上市,但上市的剂型主要是注射剂、片剂、胶囊,不能满足儿童用药需求。结论:NEML收录的抗肿瘤药物已不能完全满足我国儿童的用药需求,建议参考EMLc,加快制定适宜我国的儿童基本药物目录;同时,建议国家出台相关激励政策,激励生产企业研发儿童药品,保障儿童用药的安全、有效和可及。
Objective:To provide reference for the formulation of the National Essential Medicines List for children in China.Methods:A descriptive analysis was used to compare the differences in varieties,dosage forms,specifications,and indications of anti-tumor drugs included in the 2023 edition of the World Health Organization(WHO)Essential Medicines List for Children(EMLc)and the 2018 edition of the National Essential Medicines List(NEML).Statistical analysis was performed on the market availability of the anti-tumor drugs specifically included in EMLc.Results:In terms of varieties,there were 26 drugs jointly listed in both directories,and 18 kinds of anti-tumor drugs,such as bleomycin included in the EMLc,were not included in the NEML.Regarding dosage forms,the EMLc included a more diverse range of anti-tumor drug formulations.In terms of specifications,both the EMLc and NEML included specifications suitable for children.Concerning indications,none of the drugs in the NEML were labeled with indications,only the indications for arsenic trioxide were completely identical in the EMLc,domestic formulation instructions,and the U.S.Food and Drug Administration instructions.Except for filgrastim and rasburicase,all the unique anti-tumor drugs listed in the EMLc were available in China,but the available formulations were mainly injections,tablets,and capsules,which did not fully meet the needs of medication for children.Conclusion:The anti-tumor drugs listed in the NEML couldn’t fully meet the medication needs of children in China,and it is recommended to accelerate the development of a list of essential medicines for children tailored to China by referencing EMLc.Additionally,the government should introduce relevant incentive policies to encourage pharmaceutical manufacturers to invest in the research and development of pediatric drugs,thereby ensuring the safety,efficacy,and accessibility of medication for children.
作者
娄鹏举
胡永新
夏旭东
刘伟
Lou Pengju;Hu Yongxin;Xia Xudong;Liu Wei(Zhengzhou Yangcheng Hospital,Zhengzhou 452470,China;The First People’s Hospital of Zhumadian,Henan Zhumadian 463000,China;Henan Provincial Drug Evaluation Center,Zhengzhou450004,China;School of Pharmaceutical Sciences,Zhengzhou University,Zhengzhou 450001,China)
出处
《儿科药学杂志》
2025年第9期15-19,共5页
Journal of Pediatric Pharmacy
基金
河南省二〇二四年科技发展计划项目,编号242400410362。
关键词
世界卫生组织儿童基本药物目录
国家基本药物目录
抗肿瘤药物
儿童
World Health Organization Essential Medicines List for Children
National Essential Medicines List
anti-tumor drugs
children
